IPHARMA provides full cycle of clinical development from early phase trials to registration and post-marketing PV.

Services

International standards and Regulatory Authorities make demands on drug developers and holders of marketing authorization to ensure safety.

IPHARMA provides the following pharmacovigilance services:

1. Pharmacovigilance system management

  • Pharmacovigilance system master file development and adaptation

  • Providing pharmacovigilance platform to drug developers and holders of marketing authorization

2. Pre-marketing pharmacovigilance

  • Safety plan development

  • Receipt, review, sending and tracking of SAE reports

  • Receipt, review, sending and tracking of SUSAR and SAR reports

  • Receipt, review, sending and tracking of DSUR and PSUR reports

  • Organizing  the work of Data safety monitoring board with the involvement of independent experts and arrangement of the meetings

  • Providing the reports to Russian and EAEU Regulatory Authorities

 

3. Post-marketing pharmacovigilance

  • Preparation of a Patient information leaflet based on the IB data and/or clinical study reports

  • Risk management plan (RMP) preparation

  • Post-marketing studies conduct

  • Receipt, review, database entry and tracking of adverse reactions, individual intolerance and other circumstances that may cause risks for health and life of a patient when using a drug

  • Analysis of databases and literature sources, search and validation of signals

  • Internal reports preparation

  • Periodic safety update reports (PSUR) reparation and its submission to the regulatory authorities of the EAEU and Russia

 

4. Pharmacovigilance Quality Assurance

  • Pharmacovigilance training

  • Pharmacovigilance audits

© 2020 IPHARMA

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